StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

The StaClear Syringe is a single-use, manually operated piston syringe intended to inject fluids into or withdraw fluids from the body, specifically for intravitreal use in ophthalmic procedures. It is offered in three configurations: SC250AN with an attached 31-gauge needle, SC250LS with a luer-slip connector, and SC250LL with a luer-lock connector. The device is sterilized by ethylene oxide and features a TriboLink-Si silicone coating for low-particulate performance.

The subject device maintains identical intended use, materials, sterilization method, shelf life extended to 5 years (versus 1 year for predicate), and syringe volume (0.25 mL) as the predicate. Primary differences include three distinct connector configurations (attached needle versus two luer types) and updated packaging: the attached-needle model uses an LLDPE bag with 20 self-contained units, while luer models use individual Tyvek pouches. All configurations meet ISO 7886-1 and perform identical barrel, plunger, and stopper materials.

ISO 7886-1:2017 (syringe performance including cleanliness, acidity/alkalinity, extractable metals per IOL limits, lubricant, dead space, leakage, plunger force, stopper fit); ISO 7864:2016 and ISO 9626:2016 (needle specifications for attached-needle model); ISO 80369-7:2021 (luer connector performance); USP <788> and <789> (particulate matter in injections and ophthalmic solutions); ISO 10993-1 (biocompatibility); ISO 11607-1:2019 (sterile barrier packaging); ASTM D4169 and F1980 (distribution simulation and accelerated aging).

The subject device is substantially equivalent because it has identical intended use, indications for use, materials, sterilization process, principle of operation, and manufacturing process flow as the legally marketed predicate device K200242. Performance testing demonstrates the subject device meets or exceeds the same industry standards (ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7) and does not raise new safety or effectiveness questions. The connector type variations and packaging differences are minor design modifications that do not affect the fundamental safety or performance of the device. The extended 5-year shelf life is supported by accelerated aging testing showing maintained sterility and performance per established standards.